Laxatives may be taken by a subject for a number of reasons. Laxatives are, for example, prescribed for certain medical indications such as the cleansing of the GI tract in preparation for a medical or surgical procedure.
Laxatives may cause diarrhea in a subject which in turn may cause electrolyte loss and acid-base imbalance.
There are numerous types of laxatives, which have a number of different mechanisms of action. Polyethylene glycol, which is also known as PEG, is an osmotic laxative that is used for irrigation of the colon and GI tract in preparation for medical and surgical procedures. A bowel preparation regimen may, for example, prescribe the ingestion of PEG by a subject until the subject passes watery yellow or clear stools. Such watery yellow or clear stools in a subject are essentially diarrhea, and may be associated with electrolyte loss and acid-base imbalance. When subjects preparing for a medical or surgical procedure either fast or eat only liquids in addition to taking a laxative, the effect of a laxative induced electrolyte loss and acid-base imbalance is typically even more significant.
PEG-3350 is sold in the U.S. in laxative compositions that typically are to be combined with a liquid solution. Examples of such products include MIRALAX® from Schering-Plough; GOLYTELY®, NULYTELY®, and HALF-LYTELY® from Braintree Laboratories Inc. (Braintree, Mass.); and the fruit flavored COLYTE® from Schwarz Pharma, Inc. (Mequon, Wis.). Liquid formulations of PEG are inconvenient, unsatisfying, and uncomfortable to the consumer, and can cause undesirable mouth-feel, and/or create a bloated, overwhelmed feeling in the consumer's stomach.